AN ACT TO AMEND TITLES 18, 29, AND 31 OF THE DELAWARE CODE RELATING TO HEALTH INSURANCE.

Delaware patients gain coverage for biomarker tests

Beginning January 1, 2028, covered Delaware plans must cover medically necessary biomarker tests that meet the law’s evidence standards. This applies to individual, group, blanket, and state employee coverage when issued, renewed, modified, altered, amended, or reissued after December 31, 2027. Biomarker tests check tissue, blood, or other samples for signs such as gene changes or protein levels. Tests must help guide diagnosis, treatment, care management, or ongoing monitoring of a disease or condition. A test qualifies through any one of five evidence sources: an FDA-approved or cleared test’s stated use; an FDA-approved drug’s indicated testing; drug-label warnings and precautions; Medicare national or local coverage decisions; or nationally recognized clinical guidelines. Qualifying tests cannot be treated as experimental. Plans must administer coverage to limit care disruptions and reduce repeat biopsies or sample collection. Existing deductibles, copays, coinsurance, network rules, other contract limits, and prior approval requirements remain allowed. Screening-only and investigational or experimental tests are not required to be covered. The mandate excludes accident-only, specified-disease, hospital indemnity, Medicare supplement, long-term care, disability income, and other limited-benefit policies.